Batch certification Clause Samples

The batch certification clause establishes the requirement for certifying groups of products or services together as a single unit, rather than individually. In practice, this means that once a batch—such as a shipment of manufactured goods or a set of deliverables—meets specified standards or passes inspection, a certificate is issued covering the entire group. This approach streamlines the certification process, reduces administrative burden, and ensures consistency across all items in the batch, ultimately facilitating efficient quality control and compliance verification.
Batch certification. 7.6.1. After detailed review of the batch documentation of each batch, GW is responsible to ensure that a Certificate of Compliance with GMP (CoC, confirmation statement) is included or attached to the CoA, Deviation Statement if applicable, that is signed by a Quality Assurance person (Qualified Person). 7.6.2. A copy of one complete Batch Record shall be sent to NOVARTIS annually and upon request.
View SourceView Similar (3)
Batch certification. Each batch exported will be accompanied by a batch certificate issued by the manufacturer (‘self certification’) after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation/product approval. When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products/drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant marketing authorisation/product approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMPs. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In the European Community the ‘qualified person’ is referred to in Article 21 of Directive 75/319/EEC, and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 (1).
View SourceView Similar (3)
Batch certification. Each batch exported will be accompanied by a batch certificate issued by the manufacturer ("self certification") after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorisation / Product Approval. When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products / drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant Marketing Authorisation / Product Approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In Switzerland the qualified person is referred to in article 10 of the IOCM-Manufacturing Directive (May 18, 1995, No. 241.11) and in articles 4 and 5 of the Ordinance on immunobiological products and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 1.
View Source
Batch certification. If required, upon reception of the above mentioned elements, CA shall perform the certification of the Product (or group of products included in the shipment) for the territory. Authorization to release product for the territory, sale should be provided directly and solely by CA. A certificate authorizing shipment to customer will be issued by CA.
View Source

Related to Batch certification

  • AS9100 Certification ‌ AS9100 Certification, specifies requirements for a quality management system to demonstrate the Contractor’s ability to consistently meet the customer requirements as well as statutory and regulatory requirements for the aerospace industry. An AS9100 Certification, is not mandatory; however, Contractors who desire to compete for work within the aerospace industry are encouraged to have AS9100 Certification, during the entire term of OASIS. The Contractor shall notify the OASIS CO, in writing, if there are any changes in the status of their AS9100 Certification, and provide the reasons for the change and copies of audits from an AS9100 Certification Body, as applicable. If only part of a Contractor’s organization is AS9100, certified, the Contractor shall make the distinction between which business units or sites and geographic locations have been certified.

  • S▇▇▇▇▇▇▇-▇▇▇▇▇ Certification Each Form 10-K with respect to the Trust shall include a S▇▇▇▇▇▇▇-▇▇▇▇▇ Certification in the form attached to this Agreement as Exhibit X required to be included therewith pursuant to the S▇▇▇▇▇▇▇-▇▇▇▇▇ Act. The Certificate Administrator, the Master Servicer, the Special Servicer, the Operating Advisor, the Asset Representations Reviewer (in the case of the Asset Representations Reviewer, solely with respect to reporting periods in which the Asset Representations Reviewer is required to deliver an Asset Review Report Summary), the Custodian and the Trustee shall provide (and (i) with respect to any Servicing Function Participant of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant to provide, and (ii) with respect to any other Servicing Function Participant of such party (other than any party to this Agreement), shall cause such Servicing Function Participant to provide) to the Person who signs the S▇▇▇▇▇▇▇-▇▇▇▇▇ Certification for the Trust or any Other Securitization Trust (the “Certifying Person”) no later than March 1 in the year immediately following the year as to which such Form 10-K relates or, if March 1 is not a Business Day, on the immediately following Business Day, a certification in the form attached to this Agreement as Exhibit Y-1, Exhibit Y-2, Exhibit Y-3, Exhibit Y-4, Exhibit Y-5, Exhibit Y-6, Exhibit Y-7 and Exhibit Y-8, as applicable, on which the Certifying Person, the entity for which the Certifying Person acts as an officer, and such entity’s officers, directors and Affiliates (collectively with the Certifying Person, “Certification Parties”) can reasonably rely. With respect to each Outside Serviced Mortgage Loan serviced under an Outside Servicing Agreement, the Certificate Administrator shall use commercially reasonable efforts to procure, and upon receipt deliver to the Certifying Person, a S▇▇▇▇▇▇▇-▇▇▇▇▇ back-up certification similar in form and substance to the certifications referenced in the preceding sentence, from the related Outside Servicer, the related Outside Special Servicer, the related Outside Paying Agent and the related Outside Trustee. In the event any Reporting Servicer is terminated or resigns pursuant to the terms of this Agreement, or any applicable Sub-Servicing Agreement or primary servicing agreement, as the case may be, such Reporting Servicer shall provide a certification to the Certifying Person pursuant to this Section 10.06 with respect to the period of time it was subject to this Agreement or the applicable sub-servicing or primary servicing agreement, as the case may be.

  • ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Certification Each Form 10-K with respect to the Trust shall include a ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Certification in the form attached to this Agreement as Exhibit X required to be included therewith pursuant to the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Act. The Certificate Administrator, the Master Servicer, the Special Servicer, the Operating Advisor, the Asset Representations Reviewer (in the case of the Asset Representations Reviewer, solely with respect to reporting periods in which the Asset Representations Reviewer is required to deliver an Asset Review Report Summary), the Custodian and the Trustee shall provide (and (i) with respect to any Servicing Function Participant of such party that is a Mortgage Loan Seller Sub-Servicer, shall use commercially reasonable efforts to cause such Servicing Function Participant to provide, and (ii) with respect to any other Servicing Function Participant of such party (other than any party to this Agreement), shall cause such Servicing Function Participant to provide) to the Person who signs the ▇▇▇▇▇▇▇▇-▇▇▇▇▇ Certification for the Trust or any Other Securitization Trust (the “Certifying Person”) no later than March 1 in the year immediately following the year as to which such Form 10-K relates or, if March 1 is not a Business Day, on the immediately following Business Day, a certification in the form attached to this Agreement as Exhibit Y-1, Exhibit Y-2, Exhibit Y-3, Exhibit Y-4, Exhibit Y-5, Exhibit Y-6, Exhibit Y-7 and Exhibit Y-8, as applicable, on which the Certifying Person, the entity for which the Certifying Person acts as an officer, and such entity’s officers, directors and Affiliates (collectively with the Certifying Person, “Certification Parties”) can reasonably rely. With respect to each Outside Serviced Mortgage Loan serviced under an Outside Servicing Agreement, the Certificate Administrator shall use commercially reasonable efforts to procure, and upon receipt deliver to the Certifying Person, a ▇▇▇▇▇▇▇▇-▇▇▇▇▇ back-up certification similar in form and substance to the certifications referenced in the preceding sentence, from the related Outside Servicer, the related Outside Special Servicer, the related Outside Paying Agent and the related Outside Trustee. In the event any Reporting Servicer is terminated or resigns pursuant to the terms of this Agreement, or any applicable Sub-Servicing Agreement or primary servicing agreement, as the case may be, such Reporting Servicer shall provide a certification to the Certifying Person pursuant to this Section 10.06 with respect to the period of time it was subject to this Agreement or the applicable sub-servicing or primary servicing agreement, as the case may be.

  • CLEC Certification 8.1 Notwithstanding any other provision of this Agreement, CenturyLink shall have no obligation to perform under this Agreement until such time as CLEC has obtained such FCC and Commission authorization(s) as may be required by Applicable Law for conducting business in the State as a competitive local exchange carrier. CLEC shall not be permitted to establish its account nor place any orders under this Agreement until it has obtained such authorization and provided proof of such to CenturyLink. For the life of this Agreement, CLEC must represent and warrant to CenturyLink that it remains a certified local provider of Telephone Exchange Service within CenturyLink’s Local Calling Area(s) in the State. At any time during the life of this Agreement, CLEC will provide a copy of its current Certificate of Operating Authority or other evidence of its status to CenturyLink upon request. CLEC’s failure to maintain such authorization(s) as may be required by Applicable Law for conducting business in the State as a CLEC shall be considered a Default of Agreement.

  • E-VERIFY CERTIFICATION Pursuant to Executive Order RP-80, Engineer certifies and ensures that for all contracts for services, Engineer shall, to the extent permitted by law, utilize the United States Department of Homeland Security’s E-Verify system during the term of this agreement to determine the eligibility of: 1. All persons employed by Engineer during the term of this agreement to perform duties within the State of Texas; and 2. All persons, including subcontractors, assigned by Engineer to perform work pursuant to this agreement. Violation of this provision constitutes a material breach of this agreement.